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The Human Medicines Regulations 2012, Section 295 is up to date with all changes known to be in force on or before 19 September 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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295.—(1) This regulation applies to an abbreviated advertisement that—
(a)relates to a medicinal product; and
(b)is wholly or mainly directed at persons qualified to prescribe or supply such products.
(2) A person may not issue an abbreviated advertisement to which this regulation applies unless it contains—
(a)the particulars set out in paragraphs 2 to 6 of Schedule 30 (particulars for advertisements to persons qualified to prescribe or supply);
(b)the statement “Information about this product, including adverse reactions, precautions, contra-indications, and method of use can be found at:”; accompanied by
(c)a web site address that corresponds to that statement; and
[F1(d)the name and address of the holder [F2of either the temporary authorisation or]—
(i)in the case of a medicinal product for sale or supply in Great Britain, of the UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK) for the medicinal product, or
(ii)in the case of a medicinal product for sale or supply in Northern Ireland, the name and address of the holder of the UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisation, or Article 126a authorisation for the medicinal product,
or the business name and address of the part of the holder's business that is responsible for the sale or supply of the medicinal product.]
(3) The web site at the address mentioned in sub-paragraph (2)(c) must make available—
(a)the particulars set out in Schedule 30; or
(b)a copy of the summary of the product characteristics.
(4) In this regulation, “abbreviated advertisement” means an advertisement, other than a loose insert, that—
(a)does not exceed 420 square centimetres in size; and
(b)appears in a publication sent or delivered wholly or mainly to persons qualified to prescribe or supply medicinal products.
[F3(4A) In the application of this regulation to a medicinal product for sale or supply—
(a)in Northern Ireland only, the requirements of this regulation must be met in relation to the product for sale or supply in Northern Ireland,
(b)in Great Britain only, the requirements of this regulation must be met in relation to the product for sale or supply in Great Britain, and
(c)in the whole of the United Kingdom, the requirements of this regulation must be met in relation to both—
(i)the product for sale or supply in Great Britain, and
(ii)the product for sale or supply in Northern Ireland.]
(5) This regulation is subject to regulation 301 (advertisements for registered homoeopathic medicinal products).
Textual Amendments
F1Reg. 295(2)(d) substituted (31.12.2020) by S.I. 2019/775, reg. 215(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 173)
F2Words in reg. 295(2)(d) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 14 and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 14
F3Reg. 295(4A) inserted (31.12.2020) by S.I. 2019/775, reg. 215(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 173)
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